Prospective Observational Epidemiologic Study of Maraviroc's Safety (POEM)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT00665561

First received: April 23, 2008

Last updated: May 17, 2017

Last verified: May 2017

History of Changes

Purpose

The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

Condition	Intervention
Human Immunodeficiency Virus	Drug: Maraviroc along with an optimized background antiretroviral drug regimen Drug: Optimized background antiretroviral drug regimen without maraviroc


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-experienced Hiv-1 Infected Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:

CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths [ Time Frame: Followed till 6 months after drug discontinuation up to a total of 5 years. ]
All Malignancies (AIDS defining and non-AIDS defining), Myocardial ischemia or infarction, All cause mortality [ Time Frame: Followed for a total of up to 5 years regardless of the time of drug discontinuaion. ]

Secondary Outcome Measures:

There are no Secondary Outcomes for this study. [ Time Frame: 0 ]


Estimated Enrollment:	3000
Actual Study Start Date:	March 31, 2008
Estimated Study Completion Date:	October 31, 2018
Estimated Primary Completion Date:	October 31, 2018 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Maraviroc exposed	Drug: Maraviroc along with an optimized background antiretroviral drug regimen Maraviroc prescribed per approved local label. Other Name: Selzentry
Maraviroc unexposed	Drug: Optimized background antiretroviral drug regimen without maraviroc Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.

Detailed Description:

All patients meeting the study eligibility criteria at participating sites will be invited to participate.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Treatment experienced, HIV-1 infected patients in routine clinical practice.

Criteria

Inclusion Criteria:

Treatment experienced, HIV-1 infected patients
18 years or older
Receive an approved assay for determination of HIV-1 tropism

Exclusion Criteria:

Pregnant or lactating
Using CCR5 inhibitor other than maraviroc

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665561

Show 265 Study Locations

Sponsors and Collaborators

ViiV Healthcare

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


Responsible Party:	ViiV Healthcare
ClinicalTrials.gov Identifier:	NCT00665561 History of Changes
Other Study ID Numbers:	A4001067 2007-006148-24 ( EudraCT Number ) POEM ( Other Identifier: Alias Study Number )
Study First Received:	April 23, 2008
Last Updated:	May 17, 2017

Keywords provided by ViiV Healthcare:


Maraviroc HIV-1 Safety Non-interventional

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral	Sexually Transmitted Diseases Slow Virus Diseases Maraviroc CCR5 Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on June 23, 2017

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